Atrium ProLite Hernia Mesh Lawsuit Over Infection Risk To Be Set For Trial

A federal judge has cleared the way for a hernia mesh infection lawsuit involving an Atrium ProLite patch to proceed to trial, after rejecting the manufacturer’s motion for summary judgment.

The case stems from a complaint (PDF) filed by Randy Africano in October 2017, after an allegedly non-sterile patch of ProLite mesh was used during a hernia repair surgery, which led to an infection and serious injuries.

Since at least 2012, the FDA has warned Atrium about sterility problems at some of its manufacturing facilities which may increase the risk of hernia mesh infections and other complications. In October 2012, for example, the agency sent a warning letter to the company after inspecting its facilities, noting a number of safety violations, including sterility problems.

In February 2015, a federal court in New Hampshire entered a consent decree against Atrium, blocking it from distribution of certain products made at its facilities in New Hampshire, including the ProLite Mesh.

Africano’s lawsuit indicates these deficiencies and the company’s failure to warn doctors the Atrium ProLite Mesh might not be sterile, led to his injuries.

During pretrial proceedings, Atrium filed a motion of summary judgment, seeking to have the case dismissed.

On June 10, U.S. District Judge Mary M. Rowland issued a memorandum opinion and order (PDF) which allowed Africano’s lawsuit to proceed. Even though the judge threw out Africano’s claims of defective design, she allowed his charges of manufacturing defect and failure to warn to proceed to trial.

In a separate Docket Entry posted by the clerk the same day, the Court scheduled a telephone conference for June 22, at which time a trial date will be set. The parties have also been directed to confer and be prepared to report whether a settlement conference would be productive to result the case.

Atrium Hernia Mesh Litigation

The ruling comes as Atrium faces several thousand other product liability lawsuits involving its C-Qur hernia mesh products, which are currently pending as part of a federal multidistrict litigation (MDL).

The allegations raised in this litigation involve problems with an omega-3 fatty acid (O3FA) gel coating used on the Atrium C-Qur mesh products, which was intended to reduce scar tissue formation and promote fixation of the mesh to the abdominal wall. However, plaintiffs claim that the Atrium C-Qur patch actually increased the risk of an inflammatory response, bowel adhesions and other painful complications, often resulting in additional surgery.

A series of early trial dates involving Atrium C-Qur products are expected to begin next month, to help the parties gauge how juries may respond to certain testimony and evidence that will be repeated throughout several thousand individual cases. While the outcome will not have a binding effect on other plaintiffs, it may substantially impact any hernia mesh settlements the company may reach to avoid each individual Atrium C-Qur case being set for trials in U.S. District Courts nationwide in the coming years.